MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 1 PC SHELL 38MMX54MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Local Reaction (2035); Swelling (2091); Tissue Damage (2104); Joint Dislocation (2374); Reaction (2414); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)

Event Date 06/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign: (b)(6).It is unknown at this time if the device will be returned for evaluation as the location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00316.

Event Description

It was reported the patient underwent a revision procedure of the right hip approximately 9 years post implantation due to pain, pseudotumor, dislocation, metallosis, implant wear, difficulty ambulating, tissue damage, swelling.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

The following sections were updated/corrected updated: b4, b5, d4, g3, g6, h2, h3, h4, h6, h10 the event was confirmed with medical records received.Review of the medical records identified the following: patient underwent an initial right total hip arthroscopy due to coxarthrosis with subchondral sclerosis, reduced joint spacing, and osteophytosis.No intraoperative complications were noted.-patient experienced dislocation approximately 9 years later.Patient reported pain and swelling.A ct scan confirmed pseudotumor.-ongoing complications from the initial implant include residual lumbago, coxalgia, stenotic deficit, and discrete ambulatory dysfunction.-patient was revised due to metal related pathology.Extensive damage to external rotators, dense fibrous tissue around pseudotumor.Brown liquid drained from pseudocapsule.Stem stable and well osseointegrated, left in place.Acetabular component removed without complication, bone graft placed in the acetabular bed.Pathology report confirmed reactive fibrosis with diffuse macrophage reaction and focal metallosis.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: M2A 1 PC SHELL 38MMX54MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11274437
• MDR Text Key: 230121983
• Report Number: 0001825034-2021-00315
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K011110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 15-105054
• Device Lot Number: 664230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 03/16/2021; 06/21/2021
• Supplement Dates FDA Received: 04/10/2021; 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: REF 650-0351 LOT 1319327 TAPERLOC STEM; UNKNOWN M2A 38 HEAD; UNKNOWN M2A 38 HEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 91